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ARTHORALIX 8500 - 110-0199G3

by Gendex Dental Systems

510(k) K050255

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050255 Date17 Mar 2005ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2040-2011 FDA Unclassified (pre-2012) initiated 4 Feb 2011

    There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou

    • Terminated Z-1373-2011 FDA Unclassified (pre-2012) initiated 21 Dec 2010

    The Automatic Exposure Control (AEC) feature located on the control panel of the Orthoralix 8500 Panoramic Dental X-Ray System was functional, but was subsequently disabled in units manufactured starting 5/17/10. North American units manufactured between 12/4/09 and 5/16/10 had functioning AEC buttons, but their manuals stated they were disabled. Units intended for International distribution bet

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EHD
Models / Variants
110-0199G3
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a Unit, X-ray, Extraoral With Timer, as defined in the nomenclature authority data. It is an extraoral source of x-rays used for imaging of the dento-maxillo-facial area.

It is supplied as a dental x-ray system for use in clinical settings. The device has received FDA 510(k) clearance under K050255, is classified as Class II, and is intended for dental radiographic imaging as specified in regulation 872.1800.

Other devices from Gendex Dental Systems

  • Vix Win Pro

    Class II

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ARTHORALIX 8500 used for?

    The ARTHORALIX 8500 is an extraoral source of X-rays used for imaging of the dento-maxillo-facial area, as defined in the nomenclature authority data for a Unit, X-ray, Extraoral With Timer.

  • How is the ARTHORALIX 8500 supplied and for what setting is it intended?

    It is supplied as a dental X-ray system for use in clinical settings, intended for dental radiographic imaging as specified in regulation 872.1800.

  • What regulatory clearance does the ARTHORALIX 8500 have and under which submission?

    The device has received FDA 510(k) clearance under K050255, is classified as Class II, and was found substantially equivalent to a predicate device.

  • What are the specific model numbers included in the ARTHORALIX 8500 series?

    The ARTHORALIX 8500 includes the following models: 110-0199G1, 110-0199G2, 110-0199G3, and 110-0199G4, all manufactured by Gendex Dental Systems.